ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases.

PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborator: Breast International Group
• Treatments: Fulvestrant

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage I or II primary operable breast cancer

• Surgery planned within next 1-4 weeks

• Hormone receptor status:

• Estrogen receptor positive or unknown

• No known estrogen receptor negative tumor

• Unknown progesterone receptor status eligible

PATIENT CHARACTERISTICS:

Age:

• Any age

Sex:

• Female

Menopausal status:

• Premenopausal or postmenopausal

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• No bleeding diathesis not compatible with an IM depot injection

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective non-hormonal contraception during and for 2-3 months after study

• No other prior or concurrent malignancy except adequately treated basal cell carcinoma of the skin or cancer of the uterine cervix

• No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• At least 2 months since prior ICI 182780

Radiotherapy:

• No prior radiotherapy to primary tumor

Surgery:

• See Disease Characteristics

Other:

• No other concurrent preoperative therapy for breast cancer